5.0MM SPINAL SCREWS

Orthosis, Spondylolisthesis Spinal Fixation

ORTHOTEC, L.L.C.

The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for 5.0mm Spinal Screws.

Pre-market Notification Details

Device IDK994288
510k NumberK994288
Device Name:5.0MM SPINAL SCREWS
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant ORTHOTEC, L.L.C. 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
ORTHOTEC, L.L.C. 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-20
Decision Date2000-04-10
Summary:summary

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